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2018-44676

2018-44676

Title 
Associate Clinical Trial Manager
Job Locations 
-
Singapore
Posted Date 
1/22/2018

More information about this job

Overview

PRA is one of the world’s leading CROs and we pride ourselves on the quality of our work with leading Pharmaceutical companies, the people culture and engagement of our staff as well as ensuring that we leverage the latest technologies to underpin all of our functions globally! At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. As a dynamic and organically evolving market leader, we continuously strive to seek the best talent in the market. If this sounds attractive to you, then we want to hear from you and talk to you about how you can DISCOVER YOUR PRA!

Responsibilities

PRA Health Sciences is currently looking to hire an experienced Associate Clinical Trial Manager (ACTM) to join our business and fully integrated into one of our main sponsor partners, via our Strategic Solutions division.

 

The role of Associate Clinical Trial Manager (ACTM) is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies.  The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Allergan departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.  The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. 

 

The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

 

The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all policies, and procedures. Policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements.

Qualifications

  • A./B.Sc. preferably in science or health-related field
  • Previous experience of clinical study management
  • Oversight or mentoring of more junior study monitors (direct or indirect) preferred

Knowledge and Skills

 

Employee must have a good understanding of the following:

  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
  • Knowledge of concepts of clinical research and drug development
  • General therapeutic area education and training

In addition to the essential skills, the incumbent must have the ability to:

  • Handle and prioritize multiple tasks simultaneously
  • Work effectively in a team/matrix environment
  • Understand technical, scientific and medical information
  • Handle conflict management and resolution
  • Understand clinical study budgets
  • Plan, organise, project manage and analyse data
  • Demonstrate full competency in Microsoft Office programs
  • Fluency in Chinese is a must

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